Fractyl Health(US:GUTS)2025-05-13 20:05Business Updates and Clinical Pipeline Progress Fractyl Health advanced its Revita® program for weight maintenance and Rejuva® gene therapy platform for T2D, with key clinical milestones approaching - The company focuses on addressing weight loss maintenance after patients discontinue GLP-1 therapy, a market opportunity estimated at $175 billion globally3 - Key upcoming milestones include the REVEAL-1 3-month data update in June 2025, REMAIN-1 Midpoint Cohort data in Q3 2025, and the first CTA module submission for the Rejuva platform's RJVA-001 in June 20251 Revita® Program Updates The Revita® program is evaluating its efficacy through three distinct patient cohorts within the REMAIN-1 pivotal study - The REMAIN-1 pivotal study evaluates Revita through three distinct patient cohorts: REVEAL-1, REMAIN-1 Midpoint, and REMAIN-1 Pivotal4 - Early data from the first 7 participants in the open-label REVEAL-1 Cohort showed an average weight regain of only 1.2% one month after discontinuing GLP-1 therapy, compared to a typical regain of approximately 3%, with a 3-month data update expected in June 202511 - The randomized REMAIN-1 Midpoint Cohort (45 participants) has completed enrollment, with the first 3-month randomized data on post-GLP-1 weight maintenance expected in Q3 20257 - Enrollment for the REMAIN-1 Pivotal Cohort (315 participants) was completed ahead of schedule, with 6-month primary endpoint data anticipated in the second half of 20268 Rejuva® Gene Therapy Platform The Rejuva® platform is progressing towards first-in-human studies with a regulatory submission planned for its lead candidate - The Rejuva® platform is advancing toward first-in-human studies, with plans to submit the first Clinical Trial Application (CTA) module for its lead candidate, RJVA-001, in June 202512 - RJVA-001 is being developed as a gene therapy for patients with inadequately controlled T2D, with preliminary data expected in 2026 pending regulatory authorization and first patient dosing1220 First Quarter 2025 Financial Results For Q1 2025, Fractyl Health reported a net loss primarily driven by non-cash fair value adjustments and increased operating expenses Key Financial Metrics Key financial metrics for Q1 2025 reflect increased R&D expenses and a higher net loss compared to Q1 2024 | Financial Metric | Q1 2025 | Q1 2024 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | R&D Expenses | $19.4M | $14.4M | +$5.0M | Advancement of REMAIN-1, Rejuva program, and related personnel costs | | SG&A Expenses | $5.3M | $7.1M | -$1.8M | Lower stock-based compensation, offset by increased public company costs | | Net Loss | $23.7M | $3.3M | +$20.4M | Fluctuation in non-cash fair value of notes/warrants and increased operating expenses | - As of March 31, 2025, the company held $42.1 million in cash and cash equivalents, which is expected to fund operations into the fourth quarter of 202516 Consolidated Financial Statements The consolidated financial statements provide a detailed overview of the company's balance sheet and operations for the reported periods Selected Consolidated Balance Sheet Data (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $42,108 | $67,464 | | Total assets | $83,040 | $108,077 | | Total liabilities | $76,665 | $79,653 | | Total stockholders' equity | $6,375 | $28,424 | Consolidated Statements of Operations (in thousands) | | Three Months Ended March 31, | | | :--- | :--- | :--- | | | 2025 | 2024 | | Revenue | $— | $33 | | Research and development | $19,435 | $14,424 | | Selling, general and administrative | $5,324 | $7,132 | | Loss from operations | $(24,759) | $(21,542) | | Net loss and comprehensive loss | $(23,735) | $(3,322) |